Articles and Chapters

  • Al-Huniti N, Petersson K, Tang W, Masson E, Li J. Population exposure-safety analysis of cediranib for Phase I and II studies in patients with cancer.Br J Clin Pharmacol. 2018 Apr;84(4):726-737
  • Herman AE, Chinn LW, Kotwal SG, Murray ER, Zhao R, Florero M, Lin A, Moein A, Wang R, Bremer M, Kokubu S, Serone AP, Hanze EL, Viberg A, Morimoto AM, Winter HR, Katsumoto TR. Safety, Pharmacokinetics, and Pharmacodynamics in Healthy Volunteers Treated With GDC-0853, a Selective Reversible Bruton’s Tyrosine Kinase Inhibitor.Clin Pharmacol Ther. 2018 Mar 1. doi: 10.1002/cpt.1056.
  • Røge, R. M., Bagger, J. I., Alskär, O., Kristensen, N. R., Klim, S., Holst, J. J., … & Kjellsson, M. C. Mathematical Modelling of Glucose-Dependent Insulinotropic Polypeptide and Glucagon-like Peptide-1 following Ingestion of Glucose. Basic & Clinical Pharmacology & Toxicology. Basic Clin Pharmacol Toxicol. 2017 Oct;121(4):290-297. [https://www.ncbi.nlm.nih.gov/pubmed/28374974]
  • Li J, Al-Huniti N, Henningsson A, Tang W, Masson E. Population pharmacokinetic and exposure simulation analysis for cediranib (AZD2171) in pooled Phase I/II studies in patients with cancer.Br J Clin Pharmacol. 2017 Aug;83(8):1723-1733. doi: 10.1111/bcp.13266. Epub 2017Mar27
  • Lin SM, Lu SN, Chen PT, Jeng LB, Chen SC, Hu CT, Yang SS, Le Berre MA, Liu X, Mitchell DY, Prins K, Grevel J, Peña CA, Meinhardt G. HATT: a phase IV, single-arm, open-label study of sorafenib in Taiwanese patients with advanced hepatocellular carcinoma.Hepatol Int. 2017 Mar;11(2):199-208.
  • Han K, Chanu P, Jonsson F, Winter H, Bruno R, Jin J, Stroh M. Exposure-Response and Tumor Growth Inhibition Analyses of the Monovalent Anti-c-MET Antibody Onartuzumab (MetMAb) in the Second- and Third-Line Non-Small Cell Lung Cancer. AAPS J. 2017 Mar;19(2):527-533. doi: 10.1208/s12248-016-0029-5. Epub 2016 Dec 27.
  • Lim CN, Liang S, Feng K, Chittenden J, Henry A, Mouksassi S, Birnbaum AK.Phxnlme: An R package that facilitates pharmacometric workflow of Phoenix NLME analyses. Computer Methods and Programs in Biomedicine. 2017 Mar;140:121-129. doi: 10.1016/j.cmpb.2016.12.002. Epub 2016 Dec 7.
  • Clark, R. V., Walker, A. C., Andrews, S., Turnbull, P., Wald, J. A., & Magee, M. H.. Safety,Pharmacokinetics and Pharmacologic Effects of the Selective Androgen Receptor Modulator, GSK2881078, in Healthy Men and Postmenopausal Women.  British Journal of Clinical Pharmacology (2017)
  • Ahamadi M, Freshwater T, ProhnM, Li CH, de Alwis DP, de Greef R, Elassaiss-Schaap J, Kondic A, Stone JA. Model-Based Characterization of the Pharmacokinetics of Pembrolizumab: A Humanized Anti-PD-1 Monoclonal Antibody in Advanced Solid Tumors. CPT Pharmacometrics Syst Pharmacol. 2017 Jan;6(1):49-57
  • Kakhi M, Suarez-Sharp S, Shepard T, Chittenden JT, Application of an NLME–Stochastic Deconvolution Approach to Level A IVIVC Modeling, In Journal of Pharmaceutical Sciences, Volume 106, Issue 7, 2017, Pages 1905-1916
  • Chittenden J.T., Riviere J.E. The Effects of Vehicle Mixtures on Transdermal Absorption: Thermodynamics, Mechanisms, Assessment, and Prediction. In: Dragicevic N., I. Maibach H. (eds) Percutaneous Penetration Enhancers Drug Penetration Into/Through the Skin.Springer, Berlin, Heidelberg (2017)
  • Nixon E, Brooks JD, Routh PA, Chittenden JT, Baynes RE. Pharmacokinetics of 14 C-ortho-phenylphenol following intravenous administration in pigs: Pharmacokinetics of 14 C-ortho-phenylphenol in pigs.Journal of Applied Toxicology. 2017;37:508-512.
  • Alskär, O., Karlsson, M. O. and Kjellsson, M. C. Model-Based Interspecies Scaling of Glucose Homeostasis. CPT Pharmacometrics Syst. Pharmacology.(2017) [https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/psp4.12247]
  • Okubo K, Inoue Y, Numaguchi H, Tanaka K, Saito I, Oshima N, Matsumoto Y, ProhnM, Mehta A, Nishida C, Philip G. J. Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial. Drug Assess. 2016 Sep 19;5(1):6-14. eCollection 2016.
  • Zandvliet AS, ProhnM, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.
  • Chittenden JT, Riviere JE. Assessment of penetrant and vehicle mixture properties on transdermal permeability using a mixed effect pharmacokinetic model of ex vivo porcine skin: Model of Vehicle Mixture Effects on Ex Vivo Transdermal Permeability. Biopharmaceutics & Drug Disposition. 2016;37(7):387-96.
  • Matzuka B, Chittenden J, Monteleone J, Tran H. Stochastic nonlinear mixed effects: a metformin case study.Journal of Pharmacokinetics and Pharmacodynamics. 2016;2015;43(1):85-98.

 

Conference Presentations and Posters

PAGE, ACOP, ACCP, ASCPT

  • Jonsson, F. Mercier, N.H. Prins, C. Schmitt, S. Retout. Exposure-Response Modeling of Emicizumab for the Prophylaxis of Bleeding in Hemophilia A Patients. PAGE 27 (2018) Abstr 8451 [www.page-meeting.org/?abstract=8451]
  • Eva Hanze, Lars Lindbom, Johan Wallin.Validation of Xenograft Dose Predictions for Clinical Efficacy in NSCLC. PAGE 27 (2018) Abstr 8433 [www.page-meeting.org/?abstract=8433]
  • Whitney P. Kirschbrown, Matts Kågedal, Bei Wang, Lars Lindbom, Adam Knott, Rachelle Mack, Sharareh Monemi, José Baselga, Gunter von Minckwitz, José Bines, Amit Garg. Pharmacokinetic(PK) and Exploratory Exposure-Response (E-R) Analysis Of Pertuzumab (P) In Patients (PTS) With Operable HER2-Positive Early Breast Cancer (EBC).ASCPT 2018
  • Hoffmann, J. Wald, H. Li, I. Kaul, P.S. Watson, B. Berner, G.G. Nomikos. PHARMACOKINETICS AND SAFETY OF SAGE‐217 CAPSULES IN HEALTHY SUBJECTS.ASCPT Conference, 2018
  • Venkatesh Pilla Reddy, Jinqiang Zhang, Mei Wang, Klas Petersson, Teresa Klinowska, Owen R. Jones. Pharmacokinetic-pharmacodynamic modeling approach to inform the level and duration of HER2 kinase inhibition required to demonstrate the efficacy in subcutaneous xenograft and orthotopic mouse tumor models.AcoP8 abstracts J Pharmacokinet Pharmacodyn (2017) 44:S11–S143
  • Yoshida K, Petersson K, Wald J, Viberg A, Gibiansky L, Chinn L, Quartino A. Two targets TMDD model described nonlinear pharmacokinetics of a bispecific antibody for Fibroblast Growth Factor Receptor 1/βKlotho Complex in humans. AcoP8 abstracts J Pharmacokinet Pharmacodyn (2017) 44:S11–S143
  • Prohn, D. Zhang, C. Davis, P. Sabato, S. Macha, A. Viberg, K. Dykstra, C. R. Cho. Nonlinear Pharmacokinetics of Letermovir (LET) Following Oral and IV Administration in Healthy Volunteers. Acop8 2017.
  • Freshwater T, Jadhav PR, Hodge L, Hanley WD. Competitive Landscape Model Using Meta-analysis and Simulation-based Evaluation for Phase IIb Study Design of MRL-1 Being Developed for the Treatment of Rheumatoid Arthritis. Poster PAGE meeting 2016

 

Other Conferences

  • Stass H., Willmann S., Henningson A. P1043 Population Pharmacokinetic (PK) Analysis in Non-Cystic Fibrosis Bronchiectasis (NCFB) Patients Under 32.5 mg bid Intermittent Therapy with Ciprofloxacin Dry Powder for Inhalation (DPI)ATS 2017 International Conference, May 19-24, Washington DC.
  • Colquhoun H, Hoffmann E, Raines S, Wald JA, Kanes S.  Pharmacokinetics of SAGE-547 in patients with super refractory status epilepticus (P6.241). Neurology, 88(16 Supplement), pp.P6.241.
  • Hoffmann, E., Wald, JA., Raines, S., Nomikos, G., Colquhoun, H. and Kanes, S., 2017. The pharmacokinetics of SAGE-217 in Phase 1 SAD and MAD studies (P3. 008). Neurology, 88(16 Supplement), pp.P3-008.
  • Kanes SJ, Rosenthal ES, Vaitkevicius H, Claassen J, Wainwright M, Wald JA, Hoffmann E, Baird M, Quirk M, Jonas, J, Colquhoun H. SAGE-547 Injection for the treatment of super-refractory status epilepticus: primary endpoints and response rates in relationship to underlying patient characteristics and comorbidities. Neurosciences in Critical Care International Symposium.  January 2017.
  • Viberg A, Zhang D, Dykstra K, Prohn M,  Davis C, Sabato P, Macha S, Cho C. Exposure-Response Analysis of Letermovir (LET) Following Oral and IV Administration in Allogeneic Hematopoietic Cell Transplantation (HCT) Patients, (oral presentation). ASM Microbe 2017, new Orleans.
  • Anders Viberg; Da Zhang; Kevin Dykstra; Marita Prohn; Casey Davis; Philip Sabato; Sreeraj Macha; Carolyn Cho. Population Pharmacokinetics (PopPK) of Letermovir (LET) Following Oral and IV Administration in Allogeneic Hematopoietic Cell Transplantation (HCT) Recipients.ASM Microbe 2017, new Orleans.
  • Viberg AHanze E, Dietz L, Zierz R, Berndt S, Wittemer-Rump S. Abstract 2089: Therapeutic index prediction of the agonistic aglycosylated TWEAK receptor binding antibody BAY-356 AACR July 15 2016 (76) (14 Supplement) 2089